Metering technique for lateral flow assay devices

• US 7,279,136 B2
• Filed: 12/13/2005
• Issued: 10/09/2007
• Est. Priority Date: 12/13/2005
• Status: Active Grant

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Wei, Ning, Yang, Kaiyuan, Song, Xuedong, Feaster, Shawn R., Takeuchi, James M.
• Primary Examiner(s): Le; Long V.
• Assistant Examiner(s): DiRamio; Jacqueline A.
• Application Number:
  US11/301,631
• Publication Number:
  US 20070134811A1
• Time in Patent Office: 665 Days
• Field of Search: 422 55- 57, 422/61, 422/68.1, 422/100, 422/101, 435/4, 435/7.1, 435/286.4, 435/286.5, 435/287.1, 435/287.2, 435/287.7, 435/287.9, 435/288.5, 435/288.7, 436/501, 436/518, 436/17, 436/18, 436/825
• US Class Current: 422/422
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 436/825 Pretreatment for removal of interfering factors from sample
• CPC Class Codes: Y10T 436/107497 Preparation composition [e.g., lysing or precipitation, etc.]
• CPC Class Codes: Y10T 436/108331 Preservative, buffer, anticoagulant or diluent
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]
• CPC Class Codes: Y10T 436/25625 Dilution

Abstract

A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. A sample membrane is utilized having a collection region and a detection region, the collection region having a known saturation volume for the intended test sample. A barrier is defined between the collection region and the detection region. The collection region is saturated with the test sample having a volume of less than about 100 microliters so that a known volume of the test sample is contained in the collection region. The barrier is removed from between the collection region and detection region of the membrane and a diluent is supplied to the collection region of the membrane to facilitate flow of the test sample from the collection region to the detection region of the membrane.

Claims

1. A diagnostic test kit for detecting the presence of an analyte within a test sample, the test kit comprising a lateral flow assay device that further includes:

a membrane comprising a sample receiving region, a collection region and a detection region, said collection region physically defined so as to have a known saturation volume with respect to said test sample of less than about 100 microliters, such that upon saturation of said collection region, a known volume of the test sample is contained in said collection region; and

a barrier disposed between said collection region and said detection region, wherein said barrier is removed to facilitate flow of said test sample from said collection region to said detection region of said membrane;

said receiving region disposed for initial receipt of the test sample, and further comprising means for physically seperating said collection region into its known saturation volume after receipt of the test sample from said receiving region and prior to supplying a diluent to said collection region.

2. The test kit of claim 1, further comprising a plurality of detection probes within said detection region that are capable of producing a detectable signal.

3. The test kit of claim 2, wherein a receptive material is immobilized within said detection region that is capable of binding to said detection probes or conjugates thereof.

4. The test kit of claim 1, wherein said barrier comprises a soluble composition in a defined band across the width of said membrane, said soluble composition present throughout said membrane in an amount to prevent migration of the test sample from said collection region to said detection region of said membrane.

5. The test kit of claim 4, wherein said soluble composition is dissolvable by the diluent.

6. The test kit of claim 1, wherein said barrier comprises a physical separation across said membrane, and further comprising a bridge configured to be placed across said divide so that the test sample flows from said collection region to said detection region with the diluent.

7. The test kit of claim 6, wherein the test sample is whole blood, said bridge configured as a blood separation filter.

8. The test kit of claim 1, wherein said collection region comprises a portion of said receiving region and is separable from said receiving region prior to supplying the diluent to said collection region.

9. The test kit of claim 1, further comprising a channel defined in the membrane to convey the test sample to said collection region.

10. The test kit of claim 9, further comprising a sampling tip disposed at an end of said channel, said tip configured for placement adjacent to the skin of a user for receipt of a test sample of blood.

11. The test kit of claim 10, wherein said channel is separable from said collection region prior to supplying the diluent to said collection region.

12. The test kit of claim 10, wherein said channel is essentially non-conductive to the test sample.

13. The test kit of claim 10, wherein said membrane is laminated to a support, said support defining a bottom surface of said channel.

14. The test kit of claim 10, wherein said channel is treated with a hydrophobic agent.

15. The test kit of claim 1, wherein said collection region comprises of saturation volume for the test sample that is less than about 25 microliters.

16. The test kit of claim 1, wherein said collection region comprises of saturation volume for the test sample that is less than about 10 microliters.

17. A diagnostic test kit for detecting the presence of an analyte within a test sample, the test kit comprising a lateral flow assay device that further includes:

a membrane comprising a sample collection region and a detection region, said collection region physically defined so as to have a known saturation volume with respect to said test sample of less than about 100 microliters, such that upon saturation of said collection region, a known volume of the test sample is contained in said collection region;

a barrier disposed between said collection region and said detection region, wherein said barrier is removed to facilitate flow of said test sample from said collection region to said detection region of said membrane; and

a channel defined in said membrane to convey the test sample to said collection region, and further comprising means for seperating said collection region from said channel into its known saturation volume prior to supplying a diluent to said collection region.

18. The test kit of claim 17, wherein said barrier comprises a soluble composition in a defined band across the width of said membrane, said soluble composition present throughout said membrane in an amount to prevent migration of the test sample from said collection region to said detection region of said membrane.

19. The test kit of claim 18, wherein said soluble composition is dissolvable by the diluent.

20. The test kit of claim 17, wherein said barrier comprises a physical separation across said membrane, and further comprising a bridge configured to be placed across said divide so that the test sample flows from said collection region to said detection region with the diluent.

21. The test kit of claim 20, wherein the test sample is whole blood, said bridge configured as a blood separation filter.

22. The test kit of claim 17, further comprising a sampling tip disposed at an end of said channel, said tip configured for placement adjacent to the skin of a user for receipt of a test sample of blood.

23. The test kit of claim 17, wherein said channel is essentially non-conductive to the test sample.

24. The test kit of claim 17, wherein said channel is treated with a hydrophobic agent.

25. The test kit of claim 17, wherein said collection region comprises of saturation volume for the test sample that is less than about 25 microliters.

26. The test kit of claim 17, wherein said collection region comprises of saturation volume for the test sample that is less than about 10 microliters.